NCT02658955

Brief Summary

Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

January 14, 2016

Last Update Submit

October 8, 2019

Conditions

Closure of Abdominal Wall

Keywords

Abdominal wall closure

Outcome Measures

Primary Outcomes (1)

  • Incisional hernia and burst abdomen rate

    Analysis of the number of incisional hernia and burst abdomen after one year follow-up

    One year

Secondary Outcomes (3)

  • Rate of fulfillment of the protocol

    One year

  • Complication rate

    One month

  • Mesh complications rate

    One year

Study Arms (2)

Short stitch

EXPERIMENTAL

Patients in which abdominal wall is closed by short stitch technique

Procedure: Short stitch

Large stitch

NO INTERVENTION

Patients who didn't receive properly closure according with the protocol

Interventions

Short stitchPROCEDURE

Surgeons will receive instructions to change the technique of abdominal wall closure

Short stitch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients operated on by laparotomy

You may not qualify if:

  • Previous mesh
  • Concomitant hernia repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José A. Pereira

Barcelona, 08003, Spain

Location

Study Officials

  • José A. Pereira, MD

    Surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 20, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)